Marx Mathieu, Mounié Michaël, Mosnier Isabelle, Venail Frédéric, Mondain Michel, Uziel Alain, Bakhos David, Lescanne Emmanuel, N'Guyen Yann, Bernardeschi Daniele, Sterkers Olivier, Godey Benoit, Creff Gwenaëlle, Schmerber Sébastien, Bonne Nicolas-Xavier, Vincent Christophe, Fraysse Bernard, Deguine Olivier, Costa Nadège
Service d'Otologie, Otoneurologie et ORL Pédiatrique, Hôpital Pierre-Paul Riquet, CHU Toulouse Purpan, Place du Dr Baylac, Toulouse Cedex, 31059, France.
Brain & Cognition Research Centre, UMR 5549, Université Toulouse III, Toulouse, France.
Eur J Health Econ. 2024 Nov 20. doi: 10.1007/s10198-024-01740-9.
To determine the Incremental Cost-Utility Ratio (ICUR) of cochlear implantation in the treatment of adult patients with single-sided deafness (SSD) and asymmetric hearing loss (AHL).
This prospective multicenter pragmatic study including a randomized controlled trial (RCT) enrolled 155 subjects with SSD or AHL. Subjects chose a treatment option between: abstention, Contralateral Routing Of the Signal hearing aids, Bone Conduction Device or Cochlear Implant (CI). Participants who opted for CI were then randomized between two arms: "immediate CI" where the cochlear implantation was performed within one month and "initial observation" where subjects were first observed. The ICUR of CI was determined at 6 months follow-up by comparing the two arms. Utility was measured using EuroQoL- 5 dimensions (EQ-5D), to calculate the gain in Quality-Adjusted Life Years (QALY). Individual costs were extracted from the French National Health Insurance database. A Markovian MultiState (MMS) model assessed the ICUR evolution over the lifetime horizon.
Among the 155 included participants, 51 opted for a CI and were randomized. For a 6 months follow-up period, the ICUR was €422,279/QALY gained after CI. Using the MMS model, the ICUR of CI decreased to €57,561/QALY at 10 years follow-up, €38,006/QALY at 20 years, and dropped to €26,715 at 50 years. In the participants with severe tinnitus, mean ICUR was €31,105/QALY at 10 years.
CI can be considered as an efficient treatment in SSD and AHL from 20 years follow-up in the global population, and before 10 years follow-up in patients with severe associated tinnitus.
确定人工耳蜗植入治疗成人单侧耳聋（SSD）和不对称听力损失（AHL）的增量成本-效用比（ICUR）。
这项前瞻性多中心实用研究包括一项随机对照试验（RCT），纳入了155例SSD或AHL患者。受试者在以下治疗方案中进行选择：不治疗、对侧信号路由助听器、骨传导装置或人工耳蜗植入（CI）。选择CI的参与者随后被随机分为两组：“立即CI”组，即在1个月内进行人工耳蜗植入；“初始观察”组，即先对受试者进行观察。通过比较两组在6个月随访时确定CI的ICUR。使用欧洲五维健康量表（EQ-5D）测量效用，以计算质量调整生命年（QALY）的增益。个体成本从法国国家健康保险数据库中提取。马尔可夫多状态（MMS）模型评估了ICUR在整个生命周期内的演变。
在155名纳入的参与者中，51人选择了CI并被随机分组。在6个月的随访期内，CI后的ICUR为每获得1个QALY 422,279欧元。使用MMS模型，CI的ICUR在10年随访时降至每QALY 57,561欧元，20年时降至每QALY 38,006欧元，50年时降至26,715欧元。在伴有严重耳鸣的参与者中，10年时的平均ICUR为每QALY 31,105欧元。
在全球人群中，从20年随访来看，CI可被视为SSD和AHL的有效治疗方法；在伴有严重耳鸣的患者中，在10年随访之前即可考虑。
